Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine

Status: Active


In this study, Genocea is evaluating an investigational, personalized adjuvanted vaccine, GEN-009, that is being developed for the treatment of patients with solid tumors. A proprietary tool developed by Genocea, called ATLAS™ (Antigen Lead Acquisition System) will be used to identify neoantigens in each patient's tumor that are recognized by their CD4 and / or CD8 T cells. ATLAS-identified neoantigens will then be incorporated into a patient's personalized vaccine in the form of synthetic long peptides (SLPs).

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of 1 of the following tumor types:
  • Melanoma (cutaneous).
  • NSCLC.
  • SCCHN (oral, oropharyngeal, hypopharyngeal, or laryngeal).
  • Urothelial carcinoma.
  • Renal cell carcinoma (Part B only).
  • Understand the study, be willing to comply with all study procedures and sign the informed consent
  • Adequate tumor tissue available
  • ECOG performance status of 0 or 1
  • Negative pregnancy test (females of childbearing potential)
  • Agree to use of contraception during the study until at least 90 days after final GEN-009 dose
  • Adequate hematologic, liver, and kidney function Part A-specific Inclusion:
  • Have completed or will complete treatment for their disease with curative intent
  • Have no evidence of disease Part B-specific Inclusion:
  • Receiving or will initiate treatment with nivolumab or pembrolizumab per disease as listed below:
  • NSCLC: Patients with metastatic non-squamous NSCLC beginning first-line pembrolizumab in combination with pemetrexed and platinum chemotherapy, or metastatic squamous NSCLC beginning first-line pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel
  • SCCHN: Patients beginning pembrolizumab with recurrent or metastatic SCCHN with disease progression on or after a platinum-based therapy, or beginning first-line pembrolizumab for recurrent or metastatic SCCHN if tumors express PD-L1 with a Combined Positive Score (CPS) ≥ 1.
  • Cutaneous Melanoma: Patients with unresectable or metastatic cutaneous melanoma beginning nivolumab monotherapy or nivolumab in combination with ipilimumab.
  • Urothelial Carcinoma: Patients with locally advanced or metastatic urothelial carcinoma who are beginning pembrolizumab who:
  • Are not eligible for cisplatin-containing chemotherapy, and tumor is PD-L1 positive with CPS ≥ 10, or are not eligible for any platinum-containing chemotherapy, OR
  • Have had disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  • Renal Cell Carcinoma:
  • Patients with advanced RCC who have received prior anti-angiogenic therapy, and are beginning nivolumab monotherapy, OR
  • Untreated patients with intermediate or poor risk RCC based on the IMDC score who are beginning nivolumab in combination with ipilimumab.
  • Disease assessment by CT or MRI
  • Have at least 1 lesion that is measureable by RECIST 1.1
  • Agree to a tumor biopsy 50 days after first GEN-009 vaccination
  • Participants with hypothyroidism must be on thyroid replacement treatment

Exclusion Criteria

  • Received a live vaccine ≤ 28 days, or a non-live vaccine ≤ 14 days, prior to the first dose of GEN-009
  • Acute or chronic skin disorders that would interfere with injection
  • Receiving immunosuppressive therapies or systemic corticosteroids. Note: Use of topical corticosteroids or inhaled corticosteroids is acceptable
  • Allergy to the vaccine adjuvant Hiltonol (poly-ICLC)
  • Active hepatitis B or hepatitis C infection
  • HIV Positive
  • History of clinically significant cardiac condition
  • History of leptomeningeal carcinomatosis
  • Had clinically active immune-mediated disease within 5 years
  • Received a prior allogeneic stem cell transplant
  • Has primary immune deficiency
  • Received a prior solid organ transplant
  • Has malignant disease, other than the tumor types being treated in this study
  • Female patient who is pregnant, breastfeeding, or who plans to become pregnant from the signing of the informed consent until ≥ 90 days from last dose of GEN-009
  • Any condition that in the judgment of the PI would make the patient inappropriate for enrollment in the study
  • Patient has received cytotoxic chemotherapy within 4 weeks of the first leukapheresis Part A-specific Exclusion Criteria:
  • Has received or requires more than 2 adjuvant or neoadjuvant regimens (other than surgical excisions) given with curative intent prior to first GEN-009 vaccination
  • Has not recovered or stabilized from any clinically significant toxicity associated with any prior procedure or anticancer therapy

Locations & Contacts


San Diego
University of California San Diego
Status: Active
Name Not Available


University of Colorado Hospital
Status: Active
Name Not Available


Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available


Wayne State University / Karmanos Cancer Institute
Status: Active
Name Not Available

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available


University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available


M D Anderson Cancer Center
Status: Active
Name Not Available


University of Wisconsin Hospital and Clinics
Status: Approved
Name Not Available

Trial Objectives and Outline

This first-in-human study of GEN-009 will be conducted in two parts in adult patients with cutaneous melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, or renal cell carcinoma (Part B only). In Part A, the safety and immunogenicity of single-agent GEN-009 will be evaluated in patients with the above-noted tumor types who have completed treatment with curative intent for their disease (eg, surgical resection, neoadjuvant and/or adjuvant chemotherapy, and/or radiation therapy) and have no evidence of disease (NED) at the time of initiating vaccination with GEN-009. In Part B, up to 15 patients in each disease cohort will be enrolled and evaluated for safety, immunogenicity, and preliminary antitumor activity of GEN-009. Patients in Part B will receive GEN-009 at the schedule selected in Part A, in combination with a PD-1 inhibitor therapy (nivolumab or pembrolizumab) at the approved dose and schedule per the United States Package Insert (USPI). In addition, approximately 15 patients who enroll in one of the Part B disease-specific cohorts but whose disease progresses during the screening period therapy may be enrolled into a separate relapsed/refractory disease cohort.

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type


Lead Organization

Lead Organization
Genocea Biosciences, Inc.

Trial IDs

Primary ID GEN-009-101
Secondary IDs NCI-2018-01900 ID NCT03633110